2014 Annual Report of the International Union of Psychological Science to the American Psychological Association

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1 2014 Annual Report of the International Union of Psychological Science to the American Psychological Association Revision of World Health Organization s ICD-10 Mental and Behavioural Disorders Pierre L.-J. Ritchie, Ph.D. Main Representative to the World Health Organization International Union of Psychological Science January, 2015 Executive Summary This report provides a summary of activities completed in 2014 toward the revision of the World Health Organization s ICD-10 Mental and Behavioural Disorders chapter that were performed under the auspices of a contract between APA and the International Union of Psychological Sciences (IUPsyS) to provide technical assistance to the World Health Organization. The activities reported are those that are likely to be of most relevance and interest to APA. Additional information regarding any of these activities or other aspects of the project not specifically addressed in this Annual Report is available upon request. Background The World Health Organization (WHO) is a specialized agency of the United Nations whose mission is the attainment by all peoples of the highest possible level of health. WHO s constitution, ratified by all 194 WHO Member States, explicitly defines mental health as a part of health, and also describes WHO s core responsibilities. Among these constitutional responsibilities is the development and maintenance of international classification systems for health. The oldest, most central, and most historically important of WHO s classification systems is the International Classification of Diseases and Related Health Problems, currently in its 10 th version (ICD-10). The purpose of the ICD is to serve as an international standard for health information to enable the assessment and monitoring of mortality, morbidity, and other relevant parameters related to health. The WHO is the only organization with the ability to secure global cooperation and international agreement on these issues and is therefore in a unique position to initiate and promote global health standards. The ICD provides the basis for tracking epidemics and disease burden, identifying the appropriate targets of health care resources, and encouraging accountability among member countries for public health at the population level. The ICD is also among the core building blocks for the electronic health information systems that are of increasing importance in many countries. By international treaty, WHO s 194 Member States (countries) have agreed to use the ICD as the framework for the collection and reporting of health information to WHO. The ICD-10 was approved by the World Health Assembly in 1990, making the current period the longest in the history of the ICD without a major revision. The World Health Assembly, comprised of the health ministers of all WHO member countries, directed WHO to undertake the current revision of the ICD in The technical work associated with the development of the ICD-11 is scheduled for completion in Following the completion of the technical work, WHO will focus on the development of a variety of materials necessary for implementation and approval prior to the approval of the ICD-11 by the World Health Assembly in May, 2017.

2 2014 Annual Report on ICD Revision, IUPsyS 2 The ICD and Mental Health, Psychology, IUPsyS and APA The WHO Department of Mental Health and Substance Abuse is responsible for directing the technical work associated with the revision of two existing chapters of the ICD-10: the chapter on Mental and Behavioural Disorders and the Chapter on Diseases of the Nervous System, as well as portions of the chapter on Symptoms, Signs and Abnormal Clinical and Laboratory Findings and the chapter on Factors Influencing Health Status and Contact with Health Services that relate to psychological, behavioral, emotional, and relational phenomena. In addition, the WHO Department of Mental Health and Substance Abuse ICD-11 has responsibility for a new chapter in the ICD-11 on Sleep-Wake disorders. The conditions included this new chapter were divided across several chapters in ICD-10, with so-called Nonorganic Sleep Disorders included in the chapter on Mental and Behavioural Disorders, most other Sleep-Wake Disorders listed among Diseases of the Nervous System, and sleep-related breathing disorders (e.g., sleep apnea) listed in Diseases of the Respiratory System. The new ICD-11 chapter on Sleep-Wake Disorders will bring these conditions together in a way that is more consistent with current scientific evidence and clinical practice. The new chapter on Conditions Related to Sexual Health will include the conditions listed under Sexual Dysfunction, not caused by organic disorder or disease in the Mental and Behavioural Disorders chapter of ICD-10, so-called organic sexual dysfunctions listed in the ICD-10 chapter on Diseases of the Genitourinary System, as well as conditions related to gender identity (called Gender Identity Disorders in ICD-10. Major goals of the Department of Mental Health and Substance Abuse for the ICD-11 include incorporating new scientific knowledge and changes in clinical practice that have developed over the past two decades, improving the ICD-11 s effectiveness as a tool for reducing global disease burden and disability, improving the classification s clinical utility (e.g., to improve the ICD as a diagnostic tool) in daily clinical practice throughout the world, including in global primary care settings, and making the ICD-11 compatible with new health information system technology. WHO has established a number of International Advisory Groups to serve as the planning and coordinating advisory body in the update and revision process. The International Advisory Group for the Revision of ICD-10 Mental and Behavioural Disorders was charged with the primary task of advising WHO in all steps leading to the revision of the ICD-10 chapter on Mental and Behavioural disorders in line with the overall revision process. IUPsyS is represented on the Advisory Group by Ann D. Watts, Ph.D., IUPsyS Secretary-General of IUPsyS. The Advisory Group established a number of expert Working Groups to assist in its work in specific areas. Within WHO, responsibility for coordinating all activities involved in the revision of the ICD-10 Mental and Behavioural Disorders chapter is assigned to Geoffrey M. Reed, Ph.D., Senior Project Officer for the Revision of ICD-10 Mental and Behavioural Disorders, Department of Mental Health and Substance Abuse, WHO. Dr. Reed is seconded by IUPsyS to the WHO in order to conduct this work, with funding provided by APA through a contract with IUPsyS. Other national psychological associations have also contributed resources related to this project. Dr. Reed functions as a member of the WHO Secretariat and reports directly to Dr. Shekhar Saxena, Director, Department of Mental Health and Substance Abuse, WHO. Dr. Reed s responsibilities include: 1) review and synthesis of evidence related to the ICD revision, including global scientific literature and other information on current use; 2) nomination and management of expert working groups; 3) resource development; 4) production of successive draft versions of the classification; 5) management of expert participation in drafting; 6) collection and synthesis of proposals and comments; 7) design and management of field studies and field trials throughout the revision process; 8) serving as Managing Editor for the published version of the ICD-11 classification of mental and behavioral disorders; 9)

3 2014 Annual Report on ICD Revision, IUPsyS 3 preparation of related scientific publications; and 10) serving as WHO Secretariat for the International Advisory Group for the Revision of ICD-10 Mental and Behavioural Disorders. Dr. Reed has had primary responsibility for managing all of the activities to be described in this report. In executing these responsibilities, Dr. Reed works with a wide range of collaborating organizations, facilities, and individuals, including other WHO departments and programs; Departments of Health of WHO member countries; an international network of WHO Mental Health Collaborating Centers; international Field Study Centers appointed specifically by WHO for work related to the ICD revision; major academic institutions; international professional societies, consumer organizations, and nongovernmental organizations (NGOs); and a wide range of researchers and other experts Activities In the context of ongoing activities related to the ICD revision, the following major activities were completed during Development of linear structure and definitions for all ICD-11 Mental and Behavioural Disorders, Sleep-Wake Disorders, and Conditions Related to Sexual Health based on content provided by Working Groups 2. Development of field study versions of diagnostic guidelines for all ICD-11 Mental and Behavioural Disorders and categories related to sexual dysfunctions and gender identity from the ICD-11 chapter on Conditions Related to Sexual Health 3. Development of Global Clinical Practice Network of nearly 12,000 clinicians worldwide to participate in internet-based field testing of diagnostic guidelines 4. Development and implementation of case-controlled field testing program for proposed diagnostic guidelines for Mental and Behavioural Disorders in English, Chinese, French, Japanese, Russian and Spanish 5. Development of ecological implementation field study protocols for major areas of ICD-11 Mental and Behavioural Disorders 6. Implementation of clinic-based field study of Primary Health Care version of the ICD-11 classification of Mental and Behavioural Disorders (ICD-11-PHC) in five countries; data collection completed in China, Mexico, Pakistan, and Spain, ongoing in Brazil 7. Publication of more than 30 articles related to the classification of mental and behavioural disorders in ICD-11 in peer-reviewed scientific journals. The following sections provide additional information regarding these activities. 1. Linear Structure and Definitions for ICD-11 Mental and Behavioural Disorders The proposed linear structure for ICD-11 Mental and Behavioural Disorder was described in detail in the 2013 Annual Report, and a comparison with the structure of DSM-5 was provided. These proposals were based on three streams of work: 1) evidence reviews, recommendations, and rationale provided by ICD- 11 Working Groups, whose examination included both the available scientific evidence and other information about clinical application of classifications in various settings throughout the world; 2) professional surveys and formative field studies undertaken by the Department of Mental Health and Substance Abuse in order to inform decisions about the structure of the classification, which have been

4 2014 Annual Report on ICD Revision, IUPsyS 4 described in previous Annual Reports; and 3) efforts to minimize accidental, arbitrary or non-substantive differences with the DSM-5 while allowing for conceptual and substantive differences based on WHO s distinct global constituencies. In addition, some aspects of the proposed structure of ICD-11 Mental and Behavioural Disorders were based on overall policy decisions and structural requirements of the over ICD revision process, which requires consistency across chapters. The statistical version of the ICD-11 that will be used by WHO Member States as a basis for the collection and reporting of health information will contain short glossary-like definitions for each category. The definitions provided in the statistical version of the classification are intended for use by coders or clerical workers and also serves as a reference point for compatibility with other classifications, but are not recommended for use by mental health professionals because they do not provide sufficient information for clinical application. 1 The statistical version of the ICD has included brief definitions of mental disorders to support coding and statistical applications since However, a major innovation for ICD-11 is the requirement that all entities in the entire classification, and not just mental and behavioural disorders, will be accompanied by brief definitions. The complete hierarchical structure the Mental and Behavioural Disorders chapter and all definitions all definitions have been submitted for inclusion in the ICD-11 Beta Platform, though not all proposals have yet been implemented. Every proposed definition for ICD-11 Mental and Behavioural Disorders is substantively different from the corresponding definition in ICD-10 because ICD-11 definitions were newly developed based on the recommendations of the Working Groups and the ICD-11 diagnostic guidelines as these were being developed. The proposed hierarchical structure and definitions can be seen on the ICD-11 Beta Platform at Registered users can make comments and proposals. The proposed hierarchical structure of the Mental and Behavioural Disorders chapter in ICD-11 is largely similar to the structure of DSM-5, though there are several differences. A detailed comparison of the hierarchical structure of the two classifications was provided as a part of the 2013 Annual Report. Differences between the categories included in ICD-11 and DSM-5, including category names, are presented in Table 1. 1 World Health Organization (1992). The ICD-10 Classification of Mental and Behavioral Disorders: Clinical Descriptions and Diagnostic Guidelines. Geneva: Author.

5 2014 Annual Report on ICD Revision, IUPsyS 5 Table 1. Category-level comparison between proposed ICD-11 classification of Mental and Behavioural Disorders and DSM-5 Note: Table is structured according to ICD-11 blocks. Many disorders listed are equivalent in concept with different names (i.e., intended to identify the same population). When DSM-5 terms are different, most have been included as index terms for proposed ICD-11 categories; explanations for exceptions are provided in the table. This table does not provide information about different operationalization of categories in ICD-11 diagnostic guidelines as compared to DSM-5 criteria. ICD-11 DSM-5 Disorders of Intellectual Development Disorder of Intellectual Development, Provisional Developmental Language Disorder Not included, would be classified as Developmental Language Disorder, with impairment of mainly pragmatic language Developmental Speech Sound Disorder Developmental Speech Fluency Disorder Developmental Learning Disorder Developmental Motor Coordination Disorder Tourette Syndrome (in chapter on Diseases of the Nervous System) Chronic Motor Tics (in chapter on Diseases of the Nervous System) Chronic phonic tics (in chapter on Diseases of the Nervous System) Neurodevelopmental Disorders Intellectual Disability Global Developmental Delay Language Disorder (Not included as index term because disorder name is too broad and could include acquired impairments.) Social (Pragmatic) Communication Disorder Speech Sound Disorder Childhood-Onset Speech Fluency Disorder (Stuttering) Specific Learning Disorder Developmental Coordination Disorder Tourette s Disorder Persistent (Chronic) Motor or Vocal Tic Disorder Schizophrenia and Other Primary Psychotic Disorders Acute and Transient Psychotic Disorder Not included, would be classified as Schizophrenia or Other Specified Schizophrenia and Other Primary Psychotic Disorders, depending on nature of symptoms Single Episode Depressive Disorder Recurrent Depressive Disorder Dysthymic Disorder Mood Disorders Brief Psychotic Disorder Schizophreniform Disorder (Not included as index term because there is no corresponding entity in ICD-11; this is an artificially constructed disorder made necessary by DSM s 6-month duration requirement for Schizophrenia.) Major Depressive Disorder, Single Episode Major Depressive Disorder, Recurrent Episode Persistent Depressive Disorder (Dysthymia) (Not included as index term because the category is not conceptually equivalent. DSM-5 has changed this significantly from DSM-IV to

6 2014 Annual Report on ICD Revision, IUPsyS 6 ICD-11 Mixed Depressive and Anxiety Disorder Not included, would be classified as Oppositional Defiant Disorder with chronic irritability/anger Premenstrual Dysphoric Disorder (in chapter on Diseases of the Genitourinary System) Olfactory Reference Disorder Hypochondriasis Complex Post-Traumatic Stress Disorder Prolonged Grief Disorder Not included as a disorder (In ICD-11, Acute Stress Reaction is conceptualized as a normal reaction to severe stress, classified in chapter on Factors Influencing Health Status and Contact with Health Services Dissociative Motor Disorder DSM-5 include conditions that meet requirements for Major depressive disorder and persist for at least two years.) Not included, would be classified as Depressive Episode with Insufficient Symptoms (under Other Specified Depressive Disorder) Disruptive Mood Dysregulation Disorder Premenstrual Dysphoric Disorder Obsessive-Compulsive and Related Disorders Disorders Specifically Associated with Stress Dissociative Disorders Not included, would be classified as Other Specified Obsessive-Compulsive and Related Disorder Illness Anxiety Disorder or Somatic Symptom Disorder (Cases of ICD-11 Hypochondriasis without prominent somatic symptoms at the time of evaluation would be classified as Illness Anxiety Disorder; those with somatic symptoms would be classified as Somatic Symptom Disorder.) Not included, would be classified as Post- Traumatic Stress Disorder Not included Note: Proposal currently being prepared for possible inclusion in next DSM update Acute Stress Disorder (Not included as index term because, as formulated in DSM-5, this category would meet requirements for being diagnosed as a mental disorder. DSM-5 represents this as a kind of subthreshold or transitional form of PTSD. However, even the results of DSM s own analyses do not support the validity of this category.) Conversion Disorder (Functional Neurological Symptoms Disorder) (Includes a variety of specifiers that correspond to specific motor or sensory disturbance. Specific

7 2014 Annual Report on ICD Revision, IUPsyS 7 ICD-11 Dissociative Disorder Of Sensation Sensorimotor Dissociative Disorder Dissociative Amnesia With Dissociative Fugue Trance Disorder Possession Trance Disorder Complex Dissociative Intrusion Disorder Bodily Distress Disorder Rumination-Regurgitation Disorder Disorders Due to the Use of Alcohol Disorders Due to Use of Opioids Disorders Due to the Use of Cannabinoids Disorders Due to Use of Sedatives, Hypnotics or Anxiolytics Disorders Due to the Use of Cocaine Disorders Due to the Use of Stimulants (including Amphetamines but excluding Caffeine and Cocaine) Disorders due to Use of Caffeine Disorders Due to the Use of Hallucinogens Disorders Due to the Use of Ecstasy and Related Drugs Disorders Due to the use of Dissociative Drugs including PCP and Ketamine Disorders Due to Use of Nicotine Disorders Due to the Use of Volatile Inhalants DSM-5 Functional Neurological Disorders included as index terms. Conversion Disorder not included as index term because most of its forms as listed in DSM-5 would correspond to Dissociative Motor Disorder, but with attacks or seizures would correspond to Sensorimotor Dissociative Disorder and with anesthesia or sensory loss would correspond to Dissociative Disorder of Sensation. Conversion Disorder is also a fairly obsolete term.) Not included, would be classified as Dissociative Amnesia Dissociative Trance (under Other Specified Dissociative Disorder) Not included, would be classified as Dissociative Trance (under Other Specified Dissociative Disorder) Not included, would be classified as Chronic and Recurrent Syndromes of Mixed Dissociative Symptoms (under Other Specified Dissociative Disorder) Bodily Distress Disorder Somatic Symptom Disorder Feeding and Eating Disorders Rumination Disorder Disorders Due to Substance Use Alcohol-Related Disorders Opioid-Related Disorders Cannabis-Related Disorders Sedative-, Hypnotic-, or Anxiolytic-Related Disorders Stimulant-Related Disorders Not included, would be classified under Other (or Unknown) Substance-Related Disorder Hallucinogen-Related Disorders Tobacco-Related Disorders Inhalant-Related Disorders

8 2014 Annual Report on ICD Revision, IUPsyS 8 ICD-11 Harmful Use of (relevant specific) Substance Substance Dependence (on relevant specific substance) Compulsive Sexual Behaviour Disorder Conduct-Dissocial Disorder Mild Personality Disorder Moderate Personality Disorder Severe Personality Disorder Personality Disorders Trait Domain Descriptors (multiple descriptors may be applied): Prominent Features Of Negative Affectivity Prominent Dissocial Features Prominent Features Of Disinhibition Prominent Anankastic Features Prominent Features Of Detachment Coercive Sexual Sadism Disorder Not included, would be classified as Paraphilic Disorder Involving Solitary Behaviour or Consenting Individuals based on distress or risk of injury or death Not included, would be classified as Paraphilic Disorder Involving Solitary Behaviour or Consenting Individuals based on distress or risk of injury or death Not included, would be classified as Paraphilic Disorder Involving Solitary Behaviour or Consenting Individuals based on distress or risk of injury or death Mild Neurocognitive Disorder Impulse Control Disorders Disruptive Behaviour And Dissocial Disorders DSM-5 Not included; some cases would be classified as Mild Substance Use Disorder Not included; would be classified as Moderate or Severe Substance Use Disorder Not included, would likely be classified as Other Specified Sexual Dysfunction Conduct Disorder Personality Disorders Paraphilic Disorders Neurocognitive Disorders Substantially different organization (DSM-5 retains DSM-IV Personality Disorder categories in main classification.) Conceptually similar to but much less complex than Alternative DSM-5 Model for Personality Disorders Sexual Sadism Disorder (Not included as index term because conceptual basis of category is very different. DSM-5 category includes non-coercive sexual behaviour with consenting others if the individual is distressed; this would be classified as Paraphilic disorder involving solitary behaviour or consenting individuals in ICD-11.) Sexual Masochism Disorder (requires distress) Fetishistic Disorder (requires distress) Transvestic Disorder (requires distress) Minor Neurocognitive Disorder

9 2014 Annual Report on ICD Revision, IUPsyS 9 Dementia Syndrome Amnestic Syndrome ICD-11 Psychological and Behavioural Factors Affecting Disorders or Diseases Classified Elsewhere Erectile Dysfunction Anorgasmia (can apply to males and females) Female Sexual Desire or Arousal Dysfunction Male Hypoactive Sexual Desire Dysfunction Early Ejaculation Gender Incongruence of Adolescence and Adulthood Gender Incongruence of Childhood Other Mental and Behavioural Disorders DSM-5 Major Neurocognitive Disorder Included in Major Neurocognitive Disorders Note: Etiological classification of Major and Minor Neurocognitive Disorders in DSM-5 corresponds to section on Dementia Disorders in ICD-11 chapter on Diseases of the Nervous System Psychological Factors Affecting other Medical Conditions Sexual Dysfunctions (in chapter on Conditions Related to Sexual Health) Erectile Disorder Female Orgasmic Disorder Female Sexual Interest/Arousal Disorder Male Hypoactive Sexual Desire Disorder Premature (Early) Ejaculation Gender Incongruence (in chapter on Conditions Related to Sexual Health) Gender Dysphoria in Adolescents and Adults Gender Dysphoria in Children

10 2014 Annual Report on ICD Revision, IUPsyS Development of Field Study Versions of Diagnostic Guidelines for all ICD-11 Mental and Behavioural Disorders and Categories Related to Sexual Dysfunctions and Gender Identity from the ICD-11 Chapter on Conditions Related to Sexual Health As noted above, the brief glossary definitions of proposed ICD-11 entities do not provide sufficient information for implementation by health professionals in clinical settings. From the perspective of the WHO Department of Mental Health and Substance Abuse, different versions of the ICD-10 Classification of Mental and Behavioural Disorders were necessary to meet the needs of its various users. For mental health professionals to use in implementing the ICD-10, the Department developed the Clinical Descriptions and Diagnostic Guidelines (CDDG) for ICD-10 Mental and Behavioural Disorders 2, intended for general clinical, educational, and service use. For each disorder, a description of the main clinical and associated features was provided, followed by more operationalized diagnostic guidelines designed to assist mental health clinicians in making a confident diagnosis. In addition, the CDDG add greater diagnostic specificity through more detailed categories not included in the statistical version of the classification. As with ICD-10, the WHO Department of Mental Health and Substance Abuse has focused on the development of a new version of the CDDG intended for use by mental health professionals in clinical settings as one of its principal products related to the ICD-11. An initial goal of the ICD-11 CDDG development process was to create a mechanism to ensure consistent and relatively uniform provision of diagnostic information across the various categories. To facilitate this, ICD-11 Working Groups were asked to collate diagnostic information about the disorders under their purview using a standardized template (referred to as a Content Form ) that contained prescribed sections. Because the WHO has final editorial responsibility for the ICD-11 material, the Department of Mental Health and Substance Abuse wanted to ensure that Working Groups understood that they were developing source material that would be used as a basis for the development of the CDDG as well as other versions of the ICD-11. The Content Form was thus framed in light of these objectives, and was designed to provide a combination of technical, administrative, and clinical information. A more complete description of the development process of the ICD-11 CDDG is provided in the article provided in Annex 1 3, which also includes complete diagnostic guidelines for Post-Traumatic Stress Disorder (PTSD) as an example. Note that the version of the article provided in Annex 1 consists of uncorrected page proofs, but the article will be published on February 1, and will be available as of that time on an open access basis at In comparing the ICD-11 CDDG to the DSM-5, a critical conceptual difference is between essential features as described in the ICD, and criteria in the DSM. Essential features represent those symptoms or characteristics that a clinician could reasonably expect to find in all cases of the disorder. While these lists of essential features superficially resemble diagnostic criteria in their overall format, for the most part they lack the specific and arbitrary duration thresholds and pick lists of items that characterize the diagnostic criteria sets in DSM-5. Instead, these diagnostic guidelines are intended to conform to the way clinicians actually make psychiatric diagnosis, i.e., with the flexible exercise of clinical judgment. Artificially precise language has generally been avoided. Such flexibility in language allows the clinician to differentially weigh those symptoms that are particularly severe and impairing, which is generally not possible in operationalized criteria sets because of the complexity this would require. Moreover, an effort has been made to order the Essential Features according to their importance to the diagnosis. Although for 2 World Health Organization (1992). The ICD-10 Classification of Mental and Behavioral Disorders: Clinical Descriptions and DIagnostic Guidelines. Geneva: Author. 3 First, M. B., Reed, G. M., Saxena, S., & Hyman, S. E. (in press). The development of the ICD-11 clinical descriptions and diagnostic guidelines for mental and behavioral disorders. World Psychiatry.

11 2014 Annual Report on ICD Revision, IUPsyS 11 most disorders setting requirements for a minimum number of symptoms is generally avoided, in some cases symptom thresholds are provided if they have been empirically established or there is another compelling reason for such a threshold. However, diagnostic guidelines in this format are too long and too detailed for the purposes of field testing, and that not all of the information provided in the complete CDDG version is essential for that purpose (e.g., information on differential diagnoses and qualifier applications that are not being tested in that study). Therefore, briefer versions of diagnostic guidelines are being developed for field testing that contain only three headings per category: 1) Essential (Required) Features; 2) Boundary with Other Disorders and Normality; and 3) Additional Features, which provide additional information that is relevant to the diagnosis of that particular disorder but is not diagnostically determinative (e.g., common presentations and comorbidities). An example of diagnostic guidelines for field testing for Anxiety and Fear-Related Disorders is provided as Annex 2. Development of field study versions of diagnostic guidelines for ICD-11 Mental and Behavioural Disorders is now substantively complete in nearly all areas. Guidelines are being used in international, multilingual case-controlled field studies via the internet with participants in the Global Clinical Practice Network (see following sections), and then being revised on the basis of results of the studies. The revised version will be tested in ecological implementation field studies in clinical settings. 3. Development of Global Clinical Practice Network of nearly 12,000 clinicians worldwide to participate in internet-based field testing of diagnostic guidelines The WHO Department of Mental Health and Substance Abuse via the Field Study Coordination Group (see Annex 3 for list of Field Study Coordination Group members) for ICD-11 Mental and Behavioural Disorders, a range of professional societies including IUPsyS and APA, and its global network of Collaborating Centers has recruited a worldwide pool of health professionals called the Global Clinical Practice Network (GCPN) to serve as participants in case-controlled field studies related to the development of the classification of mental and behavioural disorders in ICD-11. Any health professional who is legally authorized in her or his country to provide assessment or treatment services to individuals with mental and behavioural disorders is eligible to register online in any of nine languages (see Registrants provide extensive information about the nature of their background, experience, and practice that enables the selection of specifically targeted participant pools for case-controlled field studies. GCPN registrants agree to receive invitations to participate in internetbased field studies no more than once a month, each requiring approximately 30 minutes of their time, though they may decline to participate in any particular study. As of December 2014, the GCPN membership includes more than 11,491 clinicians from 138 countries. The two professional groups with the largest representation in the GCPN are physicians (54%), primarily psychiatrists, and psychologists (27%). A range of other mental health professions such as psychiatric nursing, social work, and occupational therapy are also represented. All global regions are represented, and the regional distribution of the GCPN closely resembles the regional distribution of mental health professionals according to WHO s Mental Health Atlas The professionals in the network represent a substantial amount of experience: the average years of clinical experience is 14.5 (SD = 10.5). Members of the GCPN must either supervise or directly provide clinical services to qualify for participation in most case-controlled field studies; 94% currently see patients, with 59% currently supervising others seeing patients. The network also represents professionals that work with a wide range of ages and specialties; this information allows the selection of samples that are specifically relevant for a given study. For example, GCPN registrants who indicate that they have special knowledge and experience in a particular area may be compared with registrants who do not. The participation of non-experts and a broad range of

12 2014 Annual Report on ICD Revision, IUPsyS 12 disciplines is particularly important given WHO's goal of developing a classification system that is usable by a health professionals who may not have advanced training in the specific topic under study. The GCPN participant pool is not a representative sample of all global clinicians but rather a broadly international, multidisciplinary, and multilingual volunteer sample that is specifically interested in ICD- 11 field studies and is therefore likely to evaluate and apply the proposed diagnostic guidelines in a careful manner. The experimental manipulations used in the case-controlled field studies permit conclusions about the impact of the proposed ICD-11 guidelines on clinical decision-making (e.g., compared to ICD-10), and the GCPN membership is sufficiently large and diverse to permit meaningful comparisons among subgroups, such as by region, language, and profession. For example, if it is observed that clinicians participating in a particular study in Spanish apply a specific guideline differently than clinicians participating in English, this effect could reflect cultural or training differences or a translation problem. The causes of such differences can be further investigated and the guidelines adjusted accordingly and, if necessary, re-tested. 4. Development and implementation of case-controlled field testing program for proposed diagnostic guidelines for Mental and Behavioural Disorders in English, Chinese, French, Japanese, Russian and Spanish Case-controlled field studies for ICD-11 Mental and Behavioural Disorders are currently being conduced by WHO with the consultation of the FSCG employ standardized patient material in the form of clinical vignettes and a systematic diagnostic decision procedure that allows for the evaluation of the specific impact of changes in the classification from ICD-10 to ICD-11 on the accuracy and consistency of diagnostic decision making. In order to test the specific effect of the different guidelines, it is necessary to control for the variability associated with clinical presentations to which the guidelines are applied and to manipulate key variables of interest. Vignette methodologies based on experimental designs are ideally and specifically suited to the examination of these research questions. Well-designed vignette studies retain both the external validity strengths of survey research and the internal validity strengths of experimental methods (see Evans et al., in press 4, Annex 4). Moreover, responses of health professionals to vignette scenarios can be highly generalizable to real world decision-making, showing greater reliability and validity than other methods without being subject to the ethical and feasibility limitations of conducting such research with real patients in clinical settings. Case-controlled studies using vignettes also have the enormous advantage that they can be conducted over the internet to facilitate participation by large numbers of clinicians around the world. 4.1 General Methodology for ICD-11 Case-Controlled Field Studies ICD-11 case-controlled field studies use experimental designs, generally to test the effect of differences between diagnostic guidelines for ICD-10 and ICD-11 on diagnostic decisions made by clinicians. After agreeing to participate in a particular study, clinicians are randomly assigned to review and use either the ICD-10 or the ICD-11 diagnostic guidelines in the specific area that is the focus of the study (e.g., disorders specifically associated with stress, feeding and eating disorders). Asking the same clinicians in a particular study to apply both the ICD-10 and the ICD-11 to the diagnosis of specific cases would create carryover and expectancy effects that would affect the result of the central comparison. Moreover, the central research question is not the clinicians comparative evaluation of the two sets of guidelines, but 4 Evans, S. C., Roberts, M. C., Keeley, J. W., Blossom, J. B., Amaro, C. M., Garcia, A. M., Stough, C. O., Canter, K. S., Robles, R., & Reed, G. M. (in press). Using vignette methodologies for study clinicians decision-making: Validity, utility, and application in ICD-11 field studies. International Journal of Clinical and Health Psychology.

13 2014 Annual Report on ICD Revision, IUPsyS 13 rather the consistency of their application to specific standardized cases. Therefore, diagnostic system used is manipulated as a between-participants variable. Participants are then presented with a series of two clinical vignettes (counterbalanced for order of presentation), selected from a small pool of pairedvignette comparisons carefully designed to investigate the effects of key changes proposed for ICD-11. For example, the introduction of a new required feature for a particular diagnosis in ICD-11 as compared to ICD-10 would be tested using two vignettes that differ systematically in the presentation of that feature while remaining equivalent in other respects. The experimental methods test whether clinicians using ICD-11 accurately identify and apply this new requirement and whether their diagnostic conclusions are different in the intended ways from those of clinicians using ICD-10. As many planned comparisons are included in a particular study as necessary to evaluate the important differences between ICD-11 and ICD-10 in the area under study. Planned paired comparisons are most meaningful if the same clinicians evaluate both vignettes; therefore, this manipulation is within-participant. For example, the proposed ICD-11 diagnostic guidelines for PTSD include re-experiencing the traumatic event in the present as a diagnostic requirement. The guideline is intended to mean that the individual experiences the traumatic event(s) as occurring again in the here and now, as opposed to reflecting on or ruminating about the event(s) and remembering the feelings experienced at the time. This requirement was not specified in the ICD-10. To test whether clinicians could accurately distinguish between reexperiencing and remembering as presented in clinical material, two vignettes were developed that manipulated this variable while including similar levels of other PTSD symptoms. This comparison was included as one of a series of eight paired comparisons included in the study on Disorders Specifically Associated with Stress, each testing a specific change in the diagnostic guidelines and to which participating clinicians were randomly assigned. Participants assigned to the re-experiencing versus remembering comparison were asked to provide diagnoses for both vignettes. Clinicians using ICD-10 should have assigned the diagnosis of PTSD to both vignettes, while clinicians using ICD-11 should have assigned the PTSD diagnosis only to the vignette that included re-experiencing as a symptom. After viewing each vignette, participants select a diagnosis from the guidelines they reviewed or a diagnosis from a different area, or indicate that no diagnosis is warranted. (Subthreshold vignettes are used to evaluate the boundary between disorder and normal variation.) Subsequent questions are adaptively programmed on the internet study platform to allow a step-by-step evaluation of the participant s decision-making process by reviewing the presence or absence of each diagnostic requirement for the disorder the clinician selected, after which participants are given an opportunity to change their diagnosis. Additional questions also assess the vignette (e.g., symptom severity, impairment, similarity to cases seen in clinical practice), the guidelines (e.g., ease of use, goodness of fit), and the clinicians diagnostic response (e.g., confidence in diagnosis, differential diagnosis). When the participant has completed this process, it is repeated for the second vignette. The design enables causal inferences related to how differences between diagnostic systems and vignette material affect clinicians diagnostic decision-making, as well as the accuracy, efficiency, and clarity of the diagnosis. The step-by-step review of each diagnostic requirement for the diagnostic category assigned permits identification of specific aspects of the diagnostic guidelines that are inconsistently evaluated by participating clinicians. Overall, these studies are a critical aspect of the ICD-11 field studies program because they provide specific information regarding categories and diagnostic requirements that seem to be problematic so that the corresponding aspects of the diagnostic guidelines can be improved and subsequently tested in additional field studies. 4.2 Vignette Development and Pretesting In the ICD-11 case-controlled field studies, much of the weight of the study s validity is carried by the vignettes, which are therefore developed and tested according to a systematic and rigorous process (see Evans et al., in press, Annex 4). Vignettes that manipulate specific variables to be used in each study are

14 2014 Annual Report on ICD Revision, IUPsyS 14 drafted by representatives of ICD-11 Working Groups, who are global experts with substantial clinical and research experience in the area to be studied. Each vignette is developed according to general guidelines developed by the FSCG and specific instructions regarding the clinical characteristics required for each vignette are specified in the study methodology. A different set of expert raters then pretests the vignettes to confirm the presence or absence of required diagnostic features, including the most appropriate diagnosis. This pre-testing process ensures that departures by participants from the intended diagnostic conclusion represent changes in diagnostic reasoning rather than ambiguous content in the vignette. Vignette developers and pre-testers used in the ICD-11 program of vignette-based field studies are always multidisciplinary and represent different world regions, including a high proportion from low- and middle-income countries and non-native English speakers. This process helps to ensure cultural neutrality of the vignettes and to reflect the intended users of the ICD-11. In addition, the vignette studies undergo rigorous processes for translation, re-testing, and implementation in all languages, including Chinese, English, French, Japanese, Russian, and Spanish. The translation of case-controlled field studies into multiple languages has improved the cross-cultural applicability of the diagnostic guidelines, as phrases that are untranslatable or unclear in the English version are modified as a result of this process. 4.3 Example Result from a Case-Controlled Field Study Above, an example is provided related to the ICD-11 requirement of re-experiencing as compared to remembering for a diagnosis of PTSD and how it was tested with paired vignettes. The first casecontrolled field study of disorders specifically associated with stress indicated that many aspects of the proposed ICD-11 guidelines were helpful in producing clearer and more consistent judgments among 1738 GCPN registrants participating in the study in three languages. However, participants did not make the distinction between re-experiencing and remembering as intended, as 68.8% of participants using ICD-11 assigned to this comparison applied the PTSD diagnosis to the remembering vignette, as compared to 81.3% for the re-experiencing vignette. Moreover, there was no difference between the participants who used the ICD-11 and the ICD-10 diagnostic guidelines as a basis for making this distinction. During the step-by-step review of diagnostic requirements, 38.6% of participants either indicated that they were aware that re-experiencing was not present in the remembering vignette or that they were not sure, but only 5.7% changed their initial diagnosis of PTSD when given the opportunity to do so. After reviewing these findings, the FSCG requested that the Working Group on Disorders Specifically Associated with Stress develop a clearer definition of re-experiencing for inclusion in the proposed diagnostic guidelines, and that the exclusion and appropriate diagnostic options under those circumstances be clarified. The revised guidelines will be used in subsequent studies. Although a negative finding, this example provides a useful illustration of how the ICD-11 field studies are specifically intended to improve the clinical utility of the diagnostic guidelines. 4.4 Alternative Methodologies Many ICD-11 case-controlled field studies follow the general methodology described above. However, other methodologies are being employed when alternative designs are better suited to specific research questions. For example, in the area of Paraphilic Disorders, the most important research question is not whether clinicians can distinguish one type of sexual behavior from another, but rather the capacity of clinicians to weigh multiple diagnostic dimensions articulated in the proposed ICD-11 diagnostic guidelines e.g., intensity and focus of sexual arousal pattern, focus on non-consenting others, distress, action, risk of harm in arriving at a decision about whether or not a disorder is present. The study methodology is based on an Item Response Theory analysis of the contribution of these different dimensions to clinicians decisions regarding the presence or absence of a paraphilic disorder through the application of the ICD-11 diagnostic guidelines to a larger set of vignettes that vary systematically along

15 2014 Annual Report on ICD Revision, IUPsyS 15 each dimension while holding others constant. 4.5 Current Status of Case-Controlled Field Studies Each case-controlled field studies proceeds according to the following steps: 1. Development of study methodology, including specification of major changes from ICD-10 to ICD-11, key questions for testing, and vignette characteristics; 2. Development of vignettes for use in study; 3. Validation pre-testing of vignettes; 4. Programming of study for implementation via the internet using Qualtrics platform; 5. Alpha testing of programming; 6. Beta testing of programming, including all study material; 7. Data collection; 8. Data analysis; 9. Translation into additional survey languages (includes Chinese, French, Japanese, Russian, and Spanish, depending on study); and 10. Feedback to Working Group and modification of diagnostic guidelines. The current status of case-controlled field studies for ICD-11 Mental and Behavioural Disorders is shown in Table 2. For the first study on Disorders Specifically Associated with Stress, data collection has been completed in three languages (English, Japanese, and Spanish), with 1738 GCPN participants. Data have been analyzed and examined by the FSCG, feedback provided to the Working Group, and the diagnostic guidelines modified based on the results of the study. A manuscript describing the study and its results is currently in preparation. For the second study on Feeding and Eating Disorders, data collection has been completed in English, French, Japanese, and Spanish and is currently in progress in Chinese. Preliminary data analysis has been conducted, and final data analysis will be completed once complete data are available for all languages. Other studies that are currently in progress are listed in Table 2. During 2015, additional studies will be conducted in additional areas, including: Disorders Due to Substance Use; Neurodevelopmental Disorders; Dissociative Disorders; Bodily Distress Disorder, and Impulse Control Disorders.

16 2014 Annual Report on ICD Revision, IUPsyS 16 Table 2. Current status of case-controlled field studies Methodology Document Vignette Construction Vignette Validation Stress FED Psyc 1 OCRD Paraph Anx Relat Mood F66 DBDD Psyc 2 & 3 Pers Programming Alpha Testing Beta Testing Data Collection Data Analysis Translation Feedback to WG Modification of Guidelines Completed In progress Stress: Disorders Specifically Associated with Stress FED: Feeding and Eating Disorders Psyc 1: Schizophrenia and Other Primary Psychotic Disorders, Study 1 OCRD: Obsessive-Compulsive and Related Disorders Paraph: Paraphilic Disorders Anx: Anxiety and Fear-Related Disorders Relat: Relational Problems and Maltreatment Mood: Mood Disorders F66: Disorders associated with Sexual Development and Orientation DBDD: Disruptive Behavior and Dissocial Disorders Psyc 2 & 3: Schizophrenia and Other Primary Psychotic Disorders, Studies 2 and 3 Pers: Personality Disorders

17 2014 Annual Report on ICD Revision, IUPsyS Development of ecological implementation field study protocols for major areas of ICD-11 Mental and Behavioural Disorders Although the case-controlled studies can support specific conclusions about the differential impact of ICD-11 and ICD-10 diagnostic guidelines on clinical decision making, it is still important to test the guidelines in real clinical settings in order to confirm that they indeed lead to improvements in the diagnostic process within the context in which they will be used. Therefore, WHO plans to test the key changes for ICD-11 diagnostic guidelines in a series of strategically designed ecological field studies to evaluate potential problems with clinical utility as well as the reliability of diagnostic conclusions in clinical settings. Because it is not possible within available time and resources to test the entire system in this manner, specific areas for ecological implementation field studies have been selected based on the conditions that represent the greatest proportion of global disease burden among mental disorders and the highest levels of service utilization in mental health settings, as well as those areas in which potential implementation problems are suggested by the results of case-controlled field studies. Because these studies are considerably more expensive and labor-intensive than the internet-based case controlled field studies, they will focus on highly targeted questions using methodologies designed to provide specific evidence of the utility and reliability of the proposed ICD-11 diagnostic guidelines in clinical implementation. These methods have been selected to yield information that will be maximally useful in formulating the final versions of the diagnostic guidelines for inclusion in the published ICD-11 manual. The first arm of the ecological implementation studies will evaluate the following aspects of the clinical utility of proposed ICD-11 diagnostic guidelines: (a) their ability to aid clinicians understanding of the person s condition, (b) how well they fit the presentation of actual clinical cases, (c) their feasibility of use in regular clinical interactions, and (d) their adequacy for assessing individual patients. The clinical utility arm of the ecological implementation studies will focus on new patients presenting to participating mental health treatment settings. The participating clinician will have been trained regarding the ICD-11 diagnostic guidelines and will have them available during the patient s assessment. After the clinical assessment is completed, the participating clinician will provide detailed information about the patient s presentation and their diagnostic conclusions, including a step-by-step evaluation of the essential features of any diagnosis assigned and ratings of same the clinical utility parameters used for the case-controlled field studies. The use of common questions across the case-controlled and ecological implementation field studies will facilitate the consideration of similarities and differences and their relevance for the diagnostic guidelines. The second arm of ecological implementation studies will evaluate the inter-rater reliability of diagnostic conclusions based on the proposed ICD-11 diagnostic guidelines. The reliability arm will specifically target five groups of disorders: mood disorders, psychotic disorders, disorders specifically associated with stress, anxiety disorders, and common disorders of childhood. The reliability methodology will focus on the contribution of the diagnostic guidelines to inter-rater reliability, controlling for variance in clinical presentation or information available to the clinician. That is, the research question for the inter-rater reliability studies is whether two clinicians, based on the same information, agree on the diagnosis when using the diagnostic guidelines for ICD-11. Two clinicians who have not previously evaluated the enrolled patient will together conduct a diagnostic interview. Both clinicians will then independently provide a diagnostic assessment of the patient and will also provide a step-by-step evaluation of the essential features for each selected diagnosis (up to six) and the same clinical utility ratings used in the other studies. As in the case-controlled field studies, the step-by-step evaluation is important for determining specific sources of disagreement between pairs of clinicians. Ecological implementation field studies will be implemented through WHO s network of International